4-5 DECEMBER

Reimbursement in Europe

Tues 5th Dec

11.00am

Overview of Session

11.00 Introduction to Reimbursement In Europe Session James Rose

11.15 The EU Health MAPPS Project Erwin Heeneman

11.30Supporting start-ups & SMEs in expanding their markets (Go Global MedTech Accelerator)

Joerg Trinkwalter

11.45 CRAASH: EIT Health Moebio Bootcamp Raquel Riera

12.00 Panel Discussion and Q & A All

12.30 Session close

Introduction to Reimbursement in Europe

Dr James RoseOxford AHSN

Trends in European Healthcare

Ageing population

Escalating burden of chronic disease

Ballooning healthcare expenditure

€

Increased expectation of healthcare

Trends in European Healthcare

Life Science Industy

Healthcare

Academia

Healthcare leaders are looking to innovators for support in reshaping healthcare

• Improved Outcomes

• Improved Efficiency

• Reduced Cost

Emerging sectors expected to provide part of the answer

Pharma Regenerative

Medicine Precision Medicine

Digital Health MedTech

A long and expensive journey for SMEs

Quality, Safety and Efficacy

Doctors , HCPs or Patients must want to use

Proof of Concept

Health Technology Assessment

Payers must approve use

Only then can product or service impact Patient health

Regulation Reimbursement Adoption Development

Regulatory processes harmonised across EU

Regulation

EU-wide processes

• Medicines: EU wide requirements around quality, safety, and efficacy

• Med Tech: Directives replaced by Medical Device Regulations

• Data: Directives being replaced by GDPR

Reimbursement handled at Member State level

Reimbursement

Several National HTA processes

• HTA agencies each with different:• decision criteria • processes• timelines• submission requirements

Divergence in decision making criteria

Outcomes

Clinical Effectiveness

Cost Effectiveness

Budget Impact

HRQoL

SOC Comparators

Real World Data

Innovation

Key Requirement Nice to Have Not required

Variations in capacity and decisions on value

Source: Allen et al. Frontiers in Pharmacology 2017

Same dataset results in different decisions

Source: Akehurst et al, Value in Health, 2016

Crizotinib (Xalkori)

non-small cell lung cancerRejected

Reimbursed (ASMR III)

Added Benefit not proven

Approved with conditions

Reimbursed with conditions

Eribulin (Halaven)

metastatic breast cancerRejected

Approved with restrictions (ASMR IV)

Added Benefit not proven

Approved with conditions

No recommendation

Ipilimumab (Yervoy®)

advanced melanoma

Approved with PAS

Approved (ASMR III)

Added Benefit Approved Rejected

Delays to Reimbursement decisions vary

106

118

209

272

316

347

352

Germany

UK

Netherlands

Sweden

France

Italy

Spain

Tim

e d

elay

(in

day

s) t

o

mar

ket

acce

ss

Source: Akehurst et al, Value in Health 2016

Average number of days from regulatory approval to published reimbursement decision (medicines)

Early Access Pathways for Innovative Products

Early Access to Medicines Scheme• Rapid access to patients• Not reimbursed • Potentially prioritised HTA• Accelerated mandate for commissioning

Temporary Authorization for Use (ATU) • Product reimbursed at manufacturers price• HTA after ATU period• Reimbursement decision based on SMR• Price renegotiated on ASMR rating

Medicines

Medical Devices

Early Access Pathways for Innovative Products

NUB Payments• Significant lead time to establish new code• Hospitals apply for reimbursement during that

period

Innovation and Technology Tariff / Payment• Innovative medical devices and digital tech• Can lead to complete system wide reimbursement• Support in spread across England from AHSNs

Widespread adoption very rarely automatic

Adoption and Access

Multitude of Regional and Local Processes

• Patient access often decided at the regional or local level

• Requires significant payer/clinician engagement

Source: NHS Digital Innovation Scorecard, July 2017

Summary

• Reimbursement across Europe is complex

• No Silver Bullet

• Important to use networks, advice and support

• Need for tools and programmes that can support SMEs in signposting, navigation, networking and knowledge sharing

THANK YOU!

eithealth.eu

Supporting small businesses with market access

The eMAPs Project

Erwin Heeneman Joerg Trinkwalter

Go Global MedTech Accelerator CRAASH: Moebio Bootcamp

Raquel Riera